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DUROGESIC DTRANS 100MCG/HR TRANSDERMAL PATCH

Active substance(s): FENTANYL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Warning and precaution

®

Durogesic DTrans 100microgram/hr
Transdermal Patch



(fentanyl)

Important things you need to know about Durogesic
DTrans transdermal patches

Durogesic DTrans is a medicinal product that could be
life-threatening to children, even if the patches have
been used. Bear in mind that a sticky patch could be
tempting to a child and in some cases may lead to a
fatal outcome.
Durogesic DTrans can have life-threatening side
effects in persons who are not using prescribed opioid
medicines on a regular basis.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
that you buy without a prescription or herbal medicines. You
should also tell your pharmacist that you are using Durogesic
DTrans patches if you buy any medicines from your pharmacy.

In particular, tell your doctor or pharmacist if you are taking:
• Other medicines for pain, such as other opioid painkillers
These patches contain a strong pain killer
(buprenorphine, nalbuphine or pentazocine)
Ensure that old patches are removed before applying a
• Medicines for helping you sleep
new one
• Medicines to help you calm down (tranquillisers) and
Patch sticking to another person
Patches must not be cut
medicines for mental conditions
The patch should be used only on the skin of the person for
Do not expose the patches to a heat source (such as a
hot water bottle)
whom it has been prescribed. Cases have been reported where • Medicines for relaxing your muscles
• Some medicines used to treat depression (such as
If you develop a fever tell your doctor immediately
a patch was accidentally stuck to a family member while in
Follow the dosage instructions carefully and only
citalopram, duloxetine escitalopram, fluoxetine,
close physical contact or sharing the same bed as the patch
change your patch every 3 days (72 hours)
fluvoxamine, paroxetine, sertraline, venlafaxine)
wearer. A patch sticking to another person (particularly a child)
If your breathing becomes shallow and weak take the
• Some medicines used to treat depression (called MAOIs)
may result in an overdose. In case the patch sticks to the skin
patch off and seek medical help
You should not take Durogesic DTrans within 14 days of
of another person, take the patch off immediately and seek
stopping these medicines.
medical attention. See also section 3 below.
The rest of this leaflet includes more detail and other
• Nefazodone a medicine used to treat depression
important information on the safe and effective use of
Take special care with Durogesic DTrans patches
• Some antihistamines (especially ones that make you
• Like some other strong painkillers, Durogesic DTrans
this medicine.
sleepy)
patches may make you unusually drowsy, and breathe
Keep this leaflet. You may need to read it again
• Some antibiotics used to treat infection, such as
more slowly or weakly. Very rarely these breathing
erythromycin, clarithromycin or troleandomycin
If you have any further questions, ask your doctor, nurse or
pharmacist
difficulties can be life threatening or even fatal in people • Medicines used to treat fungal infection, such as
itraconazole, ketoconazole, fluconazole or voriconazole
who have not used strong morphine-related painkillers (like
This medicine has been prescribed for you. Do not pass it

Medicines used to treat HIV infection, such as ritonavir or
Durogesic DTrans) or morphine before. If you, or your
on to others. It may harm them, even if their symptoms are
nelfinavir
partner or carer, notice that you or your child are breathing
the same as yours
• Medicines used to treat an irregular heart beat, such as
much more slowly or weakly then:
If you get side effects and they become serious or if you
amiodarone, diltiazem or verapamil
- Take the patch off
notice any side effects not listed in this leaflet, please tell
- Call a doctor, or go to your nearest hospital, straight away • Rifampicin (for treatment of TB)
your doctor, nurse or pharmacist
• Some medicines used to treat epilepsy (such as
- Keep moving and talking as much as possible
Please note that this leaflet also contains information about
carbamazepine, phenobarbital or phenytoin)
• If you develop a fever while wearing Durogesic DTrans
other strengths Durogesic DTrans 12, 25, 75, 100mcg/hr
Your doctor will know which medicines are safe to take with
patches, tell your doctor as this may affect the way the
Transdermal patch.
Durogesic DTrans patches. You may need to be closely
medicine passes through your skin
monitored if you are taking some of the types of medicines

Don’t
expose
the
patch
to
direct
heat
such
as
heating
In this leaflet
pads, electric blankets, hot-water bottles, heated water listed above or if you stop taking some of the types of
1. What Durogesic DTrans patches are and what they
medicines listed above, as this may affect the strength of
beds, heat or tanning lamps, intensive sun bathing,
are used for
Durogesic DTrans you need. If you are not sure if any of the
prolonged hot baths, saunas or hot whirlpool spa baths.
2. Before you use Durogesic DTrans patches
above applies to you, talk to your doctor or pharmacist before
These may affect the way the medicine is absorbed
using Durogesic DTrans patches.
3. How to use Durogesic DTrans patches
through the skin
• Check with your doctor or pharmacist before using this
4. Possible side effects
Operations or tests
medicine if you have ever had:
5. How to store Durogesic DTrans patches
If you think that you are going to have an anaesthetic, tell your
- Problems with your lungs or breathing
6. Further information
doctor or dentist that you are using Durogesic DTrans.
- Problems with your heart or blood pressure and blood
volume, liver or kidneys
Using Durogesic DTrans patches and drinking alcohol
- Brain tumours
Do not drink alcohol unless you have talked to your doctor first.
- Persistent headaches or a head injury.
Durogesic DTrans patches can make you drowsy or breathe
1. What Durogesic DTrans patches are and what
Your
doctor
might
need
to
check
you
more
closely.
more slowly. Drinking alcohol may make these effects worse.
they are used for
• If you are very ill, very thin or elderly, you may be more
The name of your medicine is Durogesic DTrans transdermal
Pregnancy and breast-feeding
sensitive to the effects of the patches
patch but will be referred to as ‘Durogesic DTrans patch’ or just
You must tell your doctor before using Durogesic DTrans
• If you suffer from a condition in which muscles become
‘patch’ throughout this leaflet.
patches if you are pregnant, think you may be pregnant or
weak and tire easily, known as myasthenia gravis, talk to
The patches help relieve pain that is very bad and long-lasting.
might become pregnant. Durogesic DTrans patches should not
your doctor or pharmacist before using Durogesic DTrans
Durogesic DTrans patch contains a medicine called fentanyl. It
be used during childbirth as the medication can affect the
patches.
belongs to a group of strong painkillers called opioids. The
breathing of the newborn child.
• Like many other strong painkillers, repeated use of the
patches come in five strengths (see section 6 overleaf). The
patches may make you become tolerant to the medicine or Do not breast-feed whilst using Durogesic DTrans patches. You
medicine passes slowly into your body through your skin.
should not breast-feed for 3 days after removing your
become dependent on it
Durogesic DTrans patch. This is because small amounts of the
• Tell your doctor if you have ever abused or been
medicine may pass into breast milk.
dependent on alcohol, prescription medicines or illegal
2. Before you use Durogesic DTrans patches
Ask your doctor or pharmacist for advice before taking any
drugs
Durogesic DTrans patches can be used in children aged 2 to
medicine if you are pregnant or breast-feeding.

Durogesic
DTrans
may
cause
constipation,
talk
to
your
16 years who have previously used opioid painkillers. If the
doctor or pharmacist for advice on how to prevent
patches have been prescribed for your child, the ‘you’ stated
Driving and using machines
constipation.
everywhere below should be read as ‘your child’.
Durogesic DTrans patches can make you drowsy. If this
• If you are not sure if any of the above applies to you, talk to
happens, do not drive or use any tools or machines.
Do not use Durogesic DTrans patches if:
your doctor or pharmacist before using Durogesic DTrans
This medicine can affect your ability to drive as it may make
• You are allergic to fentanyl, Durogesic or anything in
patches.
you sleepy or dizzy.
Durogesic DTrans patches (listed in section 6 overleaf)
• Do not drive while taking this medicine until you know how
Other makes of patch
• You have pain which lasts only for a short period
it affects you.
There
are
other
makes
of
fentanyl
transdermal
patch
available,
• Your child who is in pain is under 2 years old

It is an offence to drive if this medicine affects your ability to
but
they
are
not
all
the
same.
If
your
patch
looks
different
from
• Your child has not been treated with strong painkillers such
drive.
one you have used before you should check with your doctor or
as morphine Do not use this medicine if any of the above
pharmacist
before
using
it.
applies to you or your child. If you are not sure, talk to your
doctor or pharmacist before using Durogesic DTrans
patches.




However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or
dental problem and
- You have taken it according to the instructions given by
the prescriber or in the information provided with the
medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it
is safe for you to drive while taking this medicine.

3. How to use Durogesic DTrans patches










Monday

Thursday

Tuesday

Friday

Wednesday

Saturday

Thursday

Sunday

Friday

Monday

Saturday

Tuesday

Sunday

Wednesday

Apply the patch on a flat part of your upper body or arm

Children














Make sure your skin is completely dry, clean and cool
before you put the patch on
If you need to clean the skin, just use cold water
Do not use soap or any other cleansers, creams,
moisturisers, oils or talc before applying the patch
Do not stick a patch on straight after a hot bath or shower

at the same time on

Where to apply the patch
Adults



Putting a patch on
Step 1: Preparing the skin

Step 2: Open the pouch
Always use this medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist if you • Each patch is sealed in its own pouch
• Tear or cut open the pouch at the notch, shown by the
are not sure.
arrow
Using and changing the patches
• Gently tear or cut off the edge of the pouch completely (if
There is enough medicine in each patch to last 3 days (72
you use scissors, cut close to the sealed edge of the pouch
hours)
to avoid damaging the patch)
You should change your patch every third day, unless your
doctor has told you differently
Always remove the old patch before applying a new one
Always change your patch at the same time of day every
• Grasp both sides of the opened pouch and pull apart
3 days (72 hours)
• Take the patch out and use straight away
If you are using more than one patch, change all your
• Keep the empty pouch to dispose of the used patch later
patches at the same time
Make a note of the day, date and time you apply a patch, • Use each patch once only
• Do not take the patch out of its pouch until you are ready to
to remind you when you need to change your patch
use it
The following table shows you which day of the week to
• Inspect the patch for any damage
change your patch:
• Do not use the patch if it has been divided, cut or looks
damaged
Apply your
Change your patch
• Never divide or cut the patch
patch on



You should allow several days to pass before you put a
new patch on the same area of skin

Always apply the patch to the upper back to make it difficult
for your child to reach it or take it off
Every so often check that the patch remains stuck to the
skin
It is important that your child does not remove the patch
and put it in their mouth as this could be life-threatening or
even fatal
It may take some time before the patch becomes fully
effective. Therefore, your child might need additional
painkillers until the patches become effective. Your doctor
will advise you on this if it is needed
Children should be monitored very closely for 48 hours
after:
- The first patch has been put on
- A higher dose patch has been put on

Step 3: Peel and press







Make sure that the patch will be covered by loose clothing
and not stuck under a tight or elasticated band
Carefully peel one half of the shiny plastic backing away
from the centre of the patch. Try not to touch the sticky side
of the patch
Press this sticky part of the patch onto the skin
Remove the other part of the backing and press the whole
patch onto the skin with the palm of your hand
Hold for at least 30 seconds. Make sure it sticks well,
especially the edges

Step 4: Disposing of the patch




As soon as you take a patch off, fold it firmly in half so that
the sticky side sticks to itself
Put it back in its original pouch and put the pouch in the bin
with your household rubbish
Even used patches contain some medicine which may
harm children and may be fatal, so keep your used patches
out of the sight and reach of children

Step 5: Wash


Wash your hands afterwards with clean water

More about using Durogesic DTrans patches
How quickly will the patches work?




It may take up to a day before your first patch is working
completely
Your doctor may give you extra painkillers for the first day
or so
After this, the patch should help to relieve pain continuously
so that you can stop taking other painkillers. However, your
doctor may still prescribe extra painkillers from time to time

For you or your child, do not apply the patch on:
• The same place twice in a row.
If you forget to change your patch
• Sensitive areas that you move a lot, skin with cuts, spots or • If you forget, change your patch as soon as you remember
other skin blemishes
and make a note of the day and time. Change the patch
• Skin that is very hairy. If there is hair, do not shave it
again after 3 days (72 hours) as usual
(shaving irritates the skin). Instead, clip the hair as close to • If you are very late changing your patch, you should talk to
the skin as possible
your doctor because you might need some extra painkillers,
but do not apply an extra patch

If you use too many patches or the wrong strength
patch
If you have stuck on too many patches or the wrong strength
patch, take the patches off and contact a doctor or the nearest
hospital straight away.
Signs of overdose include trouble breathing or shallow
breathing, tiredness, extreme sleepiness, being unable to think
clearly, walk or talk normally and feeling faint, dizzy or
confused.





If a patch falls off





If a patch falls off before it needs changing, stick a new one
on straight away and make a note of the day and time. Use
a new area of skin on:
Your upper body or arm
Your child’s upper back
Leave another 3 days (72 hours) before changing the
new patch as usual
If your patches keep falling off, talk to your doctor, nurse or
pharmacist

If a patch sticks to another person (See also section 2
above)





Only use the patch on the skin of the person who it was
prescribed for
Make sure the patch does not get rubbed off and stick to
your partner or child, especially while sharing a bed or in
close contact
If a patch accidentally sticks to another person, take it off
straight away and seek immediate medical attention




The following side effects have also been reported
Very common (affects more than 1 in 10 people):




If your pain gets worse




If your pain gets worse while you are using these patches,
your doctor may try a higher strength patch, or give you
extra painkillers (or both)
If increasing the strength of the patch does not help, your
doctor may stop the patches

If you want to stop using the patches





Talk to your doctor before you stop using these patches
If you have been using them for some time your body may
have got used to them. Stopping suddenly may make you
feel unwell
If you stop using the patches, don’t start again without
asking your doctor first. You might need a different patch
strength when you restart

Everyday activities while using the patches



The patches are waterproof
You can shower or bathe while wearing a patch, but do not
scrub the patch itself
• If your doctor agrees, you can exercise or play sport while
wearing the patch
• You can also swim while wearing the patch, but: - Don’t use
hot whirlpool spa baths - Don’t put a tight or elasticated
band over the patch
• Don’t expose the patch to direct heat such as heating pads,
hot-water bottles, electric blankets, heated water beds, heat
or tanning lamps, intensive sun bathing, prolonged hot
baths or saunas. These may affect the way the medicine is
absorbed through the skin
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Durogesic DTrans patches can cause side
effects, although not everybody gets them.

Take the patch off and tell your doctor, or go to your
nearest hospital, straight away if you notice or suspect
any of the following. You may need urgent medical
treatment.

Feeling sick (nausea) or being sick (vomiting), constipation
Dizziness, drowsiness or not being able to sleep
Headache

Common (affects fewer than 1 in 10 people):







How long will you use the patches for?
Durogesic DTrans patches are for long-term pain. Your doctor
will be able to tell you how long you can expect to use the
patches.

Feeling unusually drowsy, breathing more slowly or weakly
than expected. Very rarely these breathing difficulties can
be life-threatening or even fatal, especially in people who
have not used strong opioid painkillers (like Durogesic
DTrans or morphine) before. If you, or your partner or
carer, notice that you or your child are breathing much
more slowly or weakly, follow the guidance above and keep
moving and talking as much as possible
Sudden swelling of the face or throat, severe irritation,
reddening or blistering of your skin. These may be signs of
a severe allergic reaction. This only happens in a small
number of people
Convulsions, fits or seizures. This affects fewer than 1 in
100 people
Reduced consciousness or loss of consciousness. These
affect fewer than 1 in 100 people










Allergic reaction
Awareness of unusual heart beats (also called palpitations),
fast heart rate
High blood pressure
Loss of appetite or dry mouth
Feeling nervous, worried or depressed
Confusion, hallucinations (seeing, feeling or hearing things
that are not there)
Sensation of pins and needles, shaking, feeling giddy
Muscle spasms
Stomach ache, indigestion, difficulty passing urine
Diarrhoea
Feeling cold, excessive sweating
General feelings of discomfort, tiredness, weakness
Swelling of hands, ankles or feet
Itchy skin, rashes or redness of the skin

Uncommon (affects fewer than 1 in 100 people):















Flu-like symptoms
Slow heart rate
Low blood pressure
Decreased feeling of sensitivity, especially in the skin
Blurred vision
Bluish colouration of the skin
Feeling agitated, disorientated, excited or unusually
carefree
Loss of memory
Eczema and/or other skin disorders including dermatitis
where the patch is placed
Disorders of sexual function
Complete obstruction of the intestine
Muscle twitching
Fever, body temperature changes
Drug withdrawal effects (such as sickness, feeling sick,
diarrhoea, anxiety or shivering)

Rare side effects (probably affecting fewer than 1 in
1,000 people):



Tiny pupils
Incomplete obstruction of the small or large intestine

The following side effects have been reported during
clinical trials in children (up to 18 years of age):
Very common side effects (probably affecting more
than 1 in 10 people):





Headache
Feeling or being sick
Constipation, diarrhoea
Itching

Common side effects (probably affecting up to 1 in 10
people):


Allergic reaction












Loss of appetite, stomach pain
Not being able to sleep, drowsiness, tiredness, feeling
weak
Feeling worried or depressed, hallucinations (seeing,
feeling or hearing things that are not there), dizziness
Shaking, decreased feeling or sensitivity, especially in the
skin
Dry mouth
Rash, excessive sweating, redness of the skin
Muscle spasms
Difficulty passing urine
Swelling of hands, ankles or feet
Skin reactions where the patch is placed

Uncommon side effects (probably affecting fewer than
1 in 100 people):







Confusion
Sensation of pins and needles
Tiny pupils
Feeling giddy
Bluish colouration of the skin, eczema and/or other skin
disorders including dermatitis where the patch is placed
Drug withdrawal effects (such as sickness, feeling sick,
diarrhoea, anxiety or shivering), flu-like symptoms.

Accidental exposure to used and unused patches particularly in
children may be fatal.

6. Further Information
What Durogesic D Transpatch contains
The active substance is fentanyl.
Each transdermal patch contains 16.8mg fentanyl (absorption
rate approx 100micrograms/hour; active surface area 42cm2).
The other components are Polyethylene terephthalate /
ethylene vinyl acetate (backsheet), duro-Tak 87-4287 (layer of
active substance), siliconised polyethylene terephthalate
(protective film), printing ink grey.

What Durogesic D Trans patch looks like and contents
of the pack
Each patch is a rectangular shaped, clear patch with a sticky
back and marked with ‘Durogesic 100µg fentanyl/h’ in grey
printing ink. It comes in packs containing 5 patches.

Manufactured by:
Janssen Pharmaceutica, N.V. Turnhoutseweg 30, 2340 Beerse
Belgium.

Procured from within the EU and repackaged by the
Product Licence holder:

If you get any of these side effects, tell your doctor, nurse or
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
pharmacist. Skin rashes, itching or sweating (affects less than 1 HA4 0NU, UK.
in 10 people). You may notice rashes, redness or slight itching
Durogesic® DTrans® 100mcg/hr Transdermal Patch
of the skin at the site of the patch. This is usually mild and
disappears after you have removed the patch. If it does not, or
PL No: 18799/2306
CD
if the patch irritates your skin badly, tell your doctor.

POM

There have been reports of newborn infants experiencing
withdrawal effects after their mothers have used Durogesic
DTrans for a long time during pregnancy.
Like many other strong painkillers, repeated use of the patches
may make you become tolerant to the medicine or become
dependent on it. If you get any of these side effects, tell your
doctor, nurse or pharmacist.
If you switch from a different painkiller to Durogesic DTrans
patches, you may notice effects such as sickness, feeling sick,
diarrhoea, anxiety or shivering. Tell your doctor if you notice
any of these effects.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information
on the safety of this medicine

5. How to store Durogesic DTrans patches.
How long to keep Durogesic DTrans patches for
Keep out of the sight and reach of children.
Do not use the patches after the expiry date which is stated on
the carton /sachet label after ‘Exp’. The expiry date refers to the
last day of that month. If the patches are out dated, take them
to your pharmacy.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

Where you should keep the patches
Keep out of the sight and reach of children.
Do not store above 25ºC.
Store in the original package. Ensure that the sachets with
transdermal systems are kept together and intact. This
medicine can only be stored for a limited period of time.

Handling the patch
Used patches should be folded firmly in half so that the sticky
side of the patch sticks to itself. Then they should be safely
discarded by putting them back into the original pouch and
putting the pouch in the bin with your household rubbish.

Leaflet date: 20.07.2015
Durogesic and DTrans are registered trademarks of Janssen
Cilag.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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